MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number AJ2675

Device Problems Break (1069); Leak/Splash (1354); Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

Some kind of black smudging in one area and it smelled like oil of some kind [device leakage].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number aj2675, expiration date oct2021, via an unspecified route of administration from an unspecified date for severe back and hip pain.The patient medical history and concomitant medications were not reported.The patient stated she has been purchasing thermacare heatwraps l-xl size for back pain therapy for years now upon the road as they were extremely helpful for her back and hip issues.This week ((b)(6) 2019) she purchased some more and when she opened the first one there was some kind of black smudging in one area and it smelled like oil of some kind, was totally taken by surprise.She was unable to use it due to the fact she had no idea what was actually on the wrap.The patient further reported that she had one damaged thermacare heatwrap back pain therapy l-xl (with what looked like black marks on it and smelled of oil).When she opened this first one and noticed the damage.Also here were photos of said item.The action for the product and event outcome was unknown.Follow-up (18may2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: the event "some kind of black smudging in one area and it smelled like oil of some kind" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "some kind of black smudging in one area and it smelled like oil of some kind" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] some kind of black smudging in one area and it smelled like oil of some kind [device leakage].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 77-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number aj2675, expiration date oct2021, via an unspecified route of administration from an unspecified date for severe back and hip pain.The patient medical history and concomitant medications were not reported.The patient stated she has been purchasing thermacare heatwraps l-xl size for back pain therapy for years now upon the road as they were extremely helpful for her back and hip issues.This week ((b)(6) 2019) she purchased some more and when she opened the first one there was some kind of black smudging in one area and it smelled like oil of some kind, was totally taken by surprise.She was unable to use it due to the fact she had no idea what was actually on the wrap.The patient further reported that she had one damaged thermacare heatwrap back pain therapy l-xl (with what looked like black marks on it and smelled of oil).When she opened this first one and noticed the damage.Also here were photos of said item.The action for the product and event outcome was unknown.Product quality complaints provided a severity of harm rating: s3; there was reasonable suggestion of device malfunction.Additional information has been requested and will be provided as it becomes available.Follow-up (18may2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (22oct2019): new information from product quality complaints includes: severity rating (s3).Company clinical evaluation comment: the event "some kind of black smudging in one area and it smelled like oil of some kind" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "some kind of black smudging in one area and it smelled like oil of some kind" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] some kind of black smudging in one area and it smelled like oil of some kind/had black oil looking marks on them.[device leakage].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 77-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number aj2675, expiration date oct2021, via an unspecified route of administration from an unspecified date for over 8 years for severe back, hip pain and spine disc back issues.The patient medical history was not reported.Concomitant medication was none.The patient stated she has been purchasing thermacare heatwraps l-xl size for back pain therapy for years now upon the road as they were extremely helpful for her back and hip issues.This week ((b)(6) 2019) she purchased some more and when she opened the first one there was some kind of black smudging in one area and it smelled like oil of some kind, was totally taken by surprise.She was unable to use it due to the fact she had no idea what was actually on the wrap.The patient further reported that she had one damaged thermacare heatwrap back pain therapy l-xl (with what looked like black marks on it and smelled of oil).When she opened this first one and noticed the damage.Also here were photos of said item.She reported there were black oil like marks on the heat wraps and she had to toss them.The action for the product and event outcome was unknown.Product quality complaints provided a severity of harm rating: s3; there was reasonable suggestion of device malfunction.Additional information has been requested and will be provided as it becomes available.Follow-up (18may2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (22oct2019): new information from product quality complaints includes: severity rating (s3).Follow-up (18nov2019): new information received from a contactable consumer included: suspect product data (indication), deny of concomitant medication.Company clinical evaluation comment: the event "some kind of black smudging in one area and it smelled like oil of some kind" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "some kind of black smudging in one area and it smelled like oil of some kind" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Manufacturer Narrative

Process related: no.Final confirmation status: confirmed.Summary of investigation: batch aj2675 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the most probable root cause for this event was classified as method/procedure/document incorrect.A previous full complaint investigation #, # lbh us, cells damaged/leaking determined that although the complaint sub-class for this event was cells damaged/leaking, the cells of the returned complaint sample wrap were actually intact with no sign of damage.The actual defect was due to the wrap coming into contact with lubricant (food grade) within the pre-buffer.The black smudging spot observed on the returned complaint sample wrap was lube from the pre-buffer chain tops.At the time the returned complaint sample wrap was manufactured, the pre-buffer shiftly cil's instructions of sop - 63921 "equipment cleaning, inspection and lubrication (cil) procedure" include the statement "important: do not clean chain tops".This would allow any lubricant on the chain tops to come into contact with the wraps as they transition through the pre-buffer.The corrective action was a revision of sop - 63921 ¿equipment cleaning, inspection and lubrication (cil) procedure" (version 12.0, effective 29aug2019).Pre-buffer shiftly cil's instructions has replaced the statement "important: do not clean chain tops" with the statement "important: only use alcohol or water to clean chain top conveyor" (see attachment # 7).This will provide a requirement other than on a monthly basis for ensuring the cleanliness of the chain tops; therefore, decreasing the chance of the wraps contacting lube within the pre-buffer.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class delivery system damage/defect not classified received at the site name site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Site sample status was received at the site on 28may2019.Return sample evaluation: 1 wrap - wrap does not show evidence of wear.On the hook end belt-stretch material is a black substance.1 pouch, pouch is open by consumer.Carton not returned.

Event Description

Event verbatim [preferred term], some kind of black smudging in one area and it smelled like oil of some kind/had black oil looking marks on them.[device leakage], narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 77-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number aj2675, expiration date oct2021, via an unspecified route of administration from an unspecified date for over 8 years for severe back, hip pain and spine disc back issues.The patient medical history was not reported.Concomitant medication was none.The patient stated she has been purchasing thermacare heatwraps l-xl size for back pain therapy for years now upon the road as they were extremely helpful for her back and hip issues.This week ((b)(6) 2019) she purchased some more and when she opened the first one there was some kind of black smudging in one area and it smelled like oil of some kind, was totally taken by surprise.She was unable to use it due to the fact she had no idea what was actually on the wrap.The patient further reported that she had one damaged thermacare heatwrap back pain therapy l-xl (with what looked like black marks on it and smelled of oil).When she opened this first one and noticed the damage.Also here were photos of said item.She reported there were black oil like marks on the heat wraps and she had to toss them.The action for the product and event outcome was unknown.Product quality complaints provided a severity of harm rating was s3; there was reasonable suggestion of device malfunction.According to product quality complaints: process related: no.Final confirmation status: confirmed.Summary of investigation: batch aj2675 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the most probable root cause for this event was classified as method/procedure/document incorrect.A previous full complaint investigation, lbh us, cells damaged/leaking determined that although the complaint sub-class for this event was cells damaged/leaking, the cells of the returned complaint sample wrap were actually intact with no sign of damage.The actual defect was due to the wrap coming into contact with lubricant (food grade) within the pre-buffer.The black smudging spot observed on the returned complaint sample wrap was lube from the pre-buffer chain tops.At the time the returned complaint sample wrap was manufactured, the pre-buffer shiftly cil's instructions of sop-63921 "equipment cleaning, inspection and lubrication (cil) procedure" include the statement "important: do not clean chain tops".This would allow any lubricant on the chain tops to come into contact with the wraps as they transition through the pre-buffer.The corrective action was a revision of sop- 63921 "equipment cleaning, inspection and lubrication (cil) procedure" (version 12.0, effective 29aug2019).Pre-buffer shiftly cil's instructions has replaced the statement "important: do not clean chain tops" with the statement "important: only use alcohol or water to clean chain top conveyor" (see attachment # 7).This will provide a requirement other than on a monthly basis for ensuring the cleanliness of the chain tops; therefore, decreasing the chance of the wraps contacting lube within the pre-buffer.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class delivery system damage/defect not classified received at the site name site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Site sample status was received at the site on 28may2019.Return sample evaluation: 1 wrap - wrap does not show evidence of wear.On the hook end belt-stretch material is a black substance.1 pouch, pouch is open by consumer.Carton not returned.Follow-up (18may2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (22oct2019): new information from product quality complaints includes severity rating (s3).Follow-up (18nov2019): new information received from a contactable consumer included: suspect product data (indication), deny of concomitant medication.Follow-up (03jul2020): new information from product quality complaints includes return sample received by site, investigational results.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9261827
• MDR Text Key: 220012685
• Report Number: 1066015-2019-00329
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Lot Number: AJ2675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR